학술논문

Double-Negative Results Matter: A Reevaluation of Sensitivities for Detecting SARS-CoV-2 Infection Using Saliva Versus Nasopharyngeal Swabs.
Document Type
Article
Source
American Journal of Epidemiology. Mar2024, Vol. 193 Issue 3, p548-560. 13p.
Subject
*NASOPHARYNX microbiology
*SALIVA analysis
*STRUCTURAL equation modeling
*COVID-19
*PREDICTIVE tests
*META-analysis
*DISEASE prevalence
*RESEARCH funding
*COVID-19 testing
*SENSITIVITY & specificity (Statistics)
*PROBABILITY theory
Language
ISSN
0002-9262
Abstract
In a recent systematic review, Bastos et al. (Ann Intern Med. 2021;174(4):501–510) compared the sensitivities of saliva sampling and nasopharyngeal swabs in the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by assuming a composite reference standard defined as positive if either test is positive and negative if both tests are negative (double negative). Even under a perfect specificity assumption, this approach ignores the double-negative results and risks overestimating the sensitivities due to residual misclassification. In this article, we first illustrate the impact of double-negative results in the estimation of the sensitivities in a single study, and then propose a 2-step latent class meta-analysis method for reevaluating both sensitivities using the same published data set as that used in Bastos et al. by properly including the observed double-negative results. We also conduct extensive simulation studies to compare the performance of the proposed method with Bastos et al.'s method for varied levels of prevalence and between-study heterogeneity. The results demonstrate that the sensitivities are overestimated noticeably using Bastos et al.'s method, and the proposed method provides a more accurate evaluation with nearly no bias and close-to-nominal coverage probability. In conclusion, double-negative results can significantly impact the estimated sensitivities when a gold standard is absent, and thus they should be properly incorporated. [ABSTRACT FROM AUTHOR]